Senior Clinical Trial Manager
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Job Description
Senior Clinical Trial Manager overseeing clinical trials, CROs, vendors, and regulatory-quality delivery. Advancing psychedelic and psychiatric therapeutics at Definium Therapeutics.
Responsibilities:
- Provide site- and/or country-level clinical trial management and vendor/external service provider oversight
- Serve as Clinical Operational Trial Lead when assigned, overseeing cross-functional delivery from protocol synopsis through Clinical Study Report and trial-results disclosure
- Ensure high-quality deliverables within timelines, budget, SOPs, GCP/ICH guidelines, and applicable FDA and state regulations
- Review monitoring visit reports, schedules, metrics, protocol deviations, issues, and action items using Definium or CRO systems
- Serve as sponsor contact for vendors and oversee deliverables, patient enrollment, data collection, risks, timelines, and budgets
- Maintain therapeutic knowledge and familiarity with clinical protocols and projects
- Revise vendor scopes of service, budgets, plans, and timelines with CROs/vendors
- Oversee CRO monitoring team activities and deliverables
- Assist Quality Assurance with site audits
- Review and contribute to protocols, eCRF designs, laboratory manuals, monitoring guidelines, pharmacy manuals, informed consent forms, and other study documents
- Manage site contracts, budgets, vendor invoices, and accruals
- Track and coordinate investigational product, clinical trial materials, and laboratory samples
- Organize site round-table and recruitment meetings
- Participate in departmental SOP, systems, and process development
- Ensure external service provider selection and setup align with protocol requirements, budgets, and timelines
- Maintain inspection readiness, data integrity, and overall data quality
- Ensure trial-specific training for trial team members and CRO personnel
Requirements:
- BS degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy)
- Minimum of 6 years clinical trial experience in the pharmaceutical industry or CRO
- Experience with managing clinical trials or prior experience in a senior CRA role, ideally in the psychiatric space
- Willingness and ability to travel up to 20% of the time, defined by business needs
- Strong organizational skills and attention to detail
- Ability to work effectively in a fast-paced and dynamic environment
- Clinical research operational knowledge
- Project planning and management skills
- Communication and presentation skills
- Ability to manage all aspects of clinical trial execution
- Experience managing teams in a virtual environment
- Experience in vendor management strongly preferred
- Excellent leadership skills and proven ability to foster team productivity and cohesiveness
Benefits:
- 100% paid health benefits including Medical, Dental and Vision for you and your dependents
- 401(k) program with company match and vesting after the turn of the first month after your start date
- Flexible time off
- Generous parental leave
- Fun fringe perks
- Additional compensation, including bonus and equity, may be available
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